March 29, 2011 — Health care professionals continue to express outrage over the market price of Makena, a drug that prevents premature labor, after K-V Pharmaceuticals last month announced it would sell the injectable treatment for $1,500 per shot, the Washington Post reports (Stein, Washington Post, 3/28). FDA approved the drug, which is a synthetic form of the hormone progesterone, last month. Because no commercial product was previously available, the drug had been dispensed by compounding pharmacies, which made the drug to order and charged about $10 to $20 per shot.
The drugmaker has sent letters to compounding pharmacies warning them of potential FDA action if they continue to make the drug. Makena, recommended once weekly beginning in the 16th week of pregnancy, could cost as much as $30,000 over the course of a pregnancy. Ther-Rx, a K-V Pharmaceuticals subsidiary that will market Makena, said it would provide the drug to uninsured women with incomes less than $100,000 per year for a copayment of $20 or less (Women's Health Policy Report, 3/10).
Critics are concerned that the price increase could prevent health insurers from covering the treatment and that it will place even greater burdens on state Medicaid programs that already are struggling financially. There is also concern that women who have health plans that cover the drug could face thousands of dollars worth of out-of-pocket costs because of copayments and deductibles.
Hal Lawrence, vice president of practice activities at the American Congress of Obstetricians and Gynecologists, said, "I'm worried about the patients not being able to afford the medication. I'm worried about our health care system not being able to afford to pay this kind of price for a medication. And I'm worried about a process that enabled a drug that was readily available to go on to be become very expensive."
K-V Pharmaceuticals has defended the price, saying that the company spent more than $200 million to develop the drug and conduct post-market studies. However, critics point out that the main study used to show Makena's effectiveness was conducted by the National Institutes of Health and paid for by taxpayers.
George Saade, president of the Society for Maternal-Fetal Medicine, said, "It's not like this drug is something they invented," adding, "I think the company is taking advantage of their FDA approval and their monopoly to make money." Saade's group, along with ACOG and the American Academy of Pediatrics, has sent a letter to the drugmaker criticizing the price increase.
The March of Dimes, which initially praised the drug, since has opposed its price. It has received about $1 million in donations from Ther-Rx. Several members of Congress also have sent letters to K-V Pharmaceuticals opposing the price increase. Lawmakers have asked CMS and the Federal Trade Commission to investigate the justification for the price increase and whether it illegally curbs competition.
FDA officials said that while they were surprised at the cost of Makena, the agency has no authority over drug pricing. An FDA official on Friday told the Post that if requested, the agency could consider approving a lower-cost generic version of the drug for another use that physicians could then prescribe off-label to prevent premature labor. The official also said the agency will not prevent compounding pharmacies from making the drug unless there are safety concerns, the Post reports (Washington Post, 3/28).